Immunoassay for the detection of the following drug substance(s) in human urine: OPI-II


Product Overview

Immunoassay for the detection of the following drug substance(s) in human urine: OPI
DOA 1 PANEL TEST - 07RD7060-07A


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 2.00

  • Device Sizes

  • Length: 75 Millimeter
    • Length: 75 Millimeter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: DJG

    Device Name: Enzyme Immunoassay, Opiates

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: TX

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 862.3650

    Third Party Flag: Y

    Medical Specialty: TX


    Device Identifiers

    Device Id: 00817830020722

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


    GMDN ®. © GMDN Agency 2005-2024.
    Educational Resources
    Videos